Pharmacodynamic and clinical evaluation of dose and taste-optimised low volume PEG-based bowel cleansing solutions using the split-dosing intake regimen in healthy subjects and in subjects undergoing screening colonoscopy - OPT Study

orgine Ltd0 sitesAugust 9, 2012

ConditionsBowel cleansing prior to colonoscopy MedDRA version: 14.1Level: PTClassification code 10066943Term: Bowel preparationSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bowel cleansing prior to colonoscopy
Sponsor: orgine Ltd
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 9, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

orgine Ltd

Eligibility Criteria

Inclusion Criteria

•(1\) The subject’s written informed consent must be obtained prior to inclusion.
•(2\) Subjects age 40 to 70 years.
•(3\) Part B only: Subjects willing to undergo screening colonoscopy, where the subject:
•(a) is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia, or
•(b) is aged 55 to 70\.
•(4\) Part A only: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
•(5\) Females of child bearing potential must be surgically sterile, post\-menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check\-in (unless post\-menopausal).
•(6\) Willing, able and competent to complete the entire procedure and to comply with study instructions.
•(7\) Ferrous sulphate should be stopped at least one week prior to study medication.
•Are the trial subjects under 18? no

Exclusion Criteria

•(1\) Part A only: Subjects undergoing screening colonoscopy.
•(2\) Presence of current clinically significant functional gastrointestinal disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome \[IBS]).
•(3\) Regular use of laxatives or colon motility altering drugs in the last month.
•(4\) Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
•(5\) Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation, GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
•(6\) Known glucose\-6\-phosphatase dehydrogenase deficiency.
•(7\) Known phenylketonuria.
•(8\) History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
•(9\) Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
•(10\) History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.